Helsinki University Hospital
Helsinki, 00029 HUS, Finland
NCT Number: NCT04590313
A randomised, controlled trial will be performed by allocating 40 years or older patients with symptomatic hallux rigidus to arthrodesis or watchful waiting group in a ratio of 1:1. Our primary outcome will be pain during walking, assessed by the 0-10 Numeric Rating Scale (NRS) at one year after randomisation. Our secondary outcomes will be pain in rest (NRS), physical function (MOXFQ), patient satisfaction in terms of Patient-accepted Symptom State (PASS), health-related quality of life (EQ-5D-5L), activity level (The Foot and Ankle Ability Measure Sports subscale), use of analgesics or orthoses and rate of complications. Our null hypothesis is that there will be no difference between arthrodesis and watchful waiting in treatment of hallux rigidus. Our primary analysis will be done using intention-to-treat principle.
This study is active but is not currently recruiting participants.
Notify Me40 year and older
All sexes
Interventional
Not applicable
Helsinki, 00029 HUS, Finland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MTPJ I arthrodesis
Time frame: 1 year after randomisation
scale 0-10; 0=no pain, 10=worst pain
Time frame: 6 months, 1year, 2 years, 5 years
scale 0-10; 0=no pain, 10=worst pain
Time frame: 6 months, 2 years, 5 years
scale 0-10; 0=no pain, 10=worst pain
Time frame: 6 months, 1year, 2 years, 5 years
MOXFQ-score, Scale 0-100
Time frame: 6 months, 1year, 2 years, 5 years
EQ-5D-5L, Scale 0-100
Time frame: 6 months, 1year, 2 years, 5 years
Number of minor and major adversary effects
Time frame: 6 months, 1year, 2 years, 5 years
Percentage of patients with acceptable symptom state (PASS)
Time frame: 6 months, 1year, 2 years, 5 years
FAAM Sports Subscale, Scale 0-100
Time frame: 6 months, 1year, 2 years, 5 years
The use of analgesics: 1) no use of analgesics or less frequent than weekly, 2) weekly use of analgesics, 3) daily use of NSAIDS or paracetamol, 4) daily use of opioids.
The use of orthoses: yes/no
Hospital District of Helsinki and Uusimaa
Other
Treatment of Hallux Rigidus (HARD): A Prospective, Randomised, Controlled Trial of Arthrodesis Versus Watchful Waiting in the Treatment of Hallux Rigidus
Acronym: HARD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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